Trial Outcomes & Findings for Home Based Care Transitions Tailored by Cognition and Patient Activation (NCT NCT02045147)

NCT ID: NCT02045147

Last Updated: 2024-10-08

Results Overview

Patient report of number of Emergency Department Visits and number of re-admissions to the hospital within a 6 month time period was measured. Validation data was obtained from the clinical sites.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

263 participants

Primary outcome timeframe

6 months

Results posted on

2024-10-08

Participant Flow

Participant milestones

Participant milestones
Measure
Grp 1a Low Cognition, Low Activation
Group 1: Subjects will receive an 8 week care transition intervention with an Advanced Practice Registered Nurse-Nurse Practitioner (APRN-NP) and Certified Nursing Assistant (CNA). The APRN-NP will guide the care transition intervention. This group will receive the most intense intervention. Grp 1 Low Cognition, Low Activation: The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation.
Grp 2a Low Cognition, High Activation
Group 2: Subjects will receive an 8 week care transition intervention with an APRN-NP and CNA. The APRN-NP will guide the care transition intervention. This group will receive an intense intervention. Grp 2 Low Cognition, High Activation: The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation and handling stressful situations.
Grp 3aNormal Cognition, Low Activation
Group 3: Subjects will receive an 4 week care transition intervention with a Registered Nurse (RN) Coach. This group will be evaluated at four weeks, if the patient activation levels are still low, they will be referred to the 4 week APRN-NP and CNA. Grp 3 Normal Cognition, Low Activation: The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided for areas of misunderstanding. The "teach back" method is used to validate knowledge, skills and confidence. Interventions are focused on motivation and developing personal behavioral goals.
Grp 4a Normal Cognition, High Activation
Group 4: Subjects will receive the least intensive intervention delivered by a RN coach. Grp 4 Normal Cognition, High Activation: The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Focus is on maintaining behaviors during hardship and stress. Empowering, motivating and validating are strategies utilized.
Grp 1b Low Cognition, Low Activation
The comparison Group for Group 1a intervention group
Grp 2b Low Cognition, High Activation
The comparison Group for Group 2a intervention group
Grp 3b Normal Cognition, Low Activation
The comparison Group for Group 3a intervention group
Grp 4b Normal Cognition, High Activation
The comparison group for Group 4a intervention group
Overall Study
STARTED
32
44
20
36
30
46
19
36
Overall Study
COMPLETED
21
32
20
34
27
36
19
33
Overall Study
NOT COMPLETED
11
12
0
2
3
10
0
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Grp 1a Low Cognition, Low Activation
Group 1: Subjects will receive an 8 week care transition intervention with an Advanced Practice Registered Nurse-Nurse Practitioner (APRN-NP) and Certified Nursing Assistant (CNA). The APRN-NP will guide the care transition intervention. This group will receive the most intense intervention. Grp 1 Low Cognition, Low Activation: The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation.
Grp 2a Low Cognition, High Activation
Group 2: Subjects will receive an 8 week care transition intervention with an APRN-NP and CNA. The APRN-NP will guide the care transition intervention. This group will receive an intense intervention. Grp 2 Low Cognition, High Activation: The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation and handling stressful situations.
Grp 3aNormal Cognition, Low Activation
Group 3: Subjects will receive an 4 week care transition intervention with a Registered Nurse (RN) Coach. This group will be evaluated at four weeks, if the patient activation levels are still low, they will be referred to the 4 week APRN-NP and CNA. Grp 3 Normal Cognition, Low Activation: The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided for areas of misunderstanding. The "teach back" method is used to validate knowledge, skills and confidence. Interventions are focused on motivation and developing personal behavioral goals.
Grp 4a Normal Cognition, High Activation
Group 4: Subjects will receive the least intensive intervention delivered by a RN coach. Grp 4 Normal Cognition, High Activation: The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Focus is on maintaining behaviors during hardship and stress. Empowering, motivating and validating are strategies utilized.
Grp 1b Low Cognition, Low Activation
The comparison Group for Group 1a intervention group
Grp 2b Low Cognition, High Activation
The comparison Group for Group 2a intervention group
Grp 3b Normal Cognition, Low Activation
The comparison Group for Group 3a intervention group
Grp 4b Normal Cognition, High Activation
The comparison group for Group 4a intervention group
Overall Study
Withdrawal by Subject
2
0
0
0
0
0
0
1
Overall Study
Did not meet inclusion criteria at hospital discharge
9
12
0
2
3
10
0
2

Baseline Characteristics

Home Based Care Transitions Tailored by Cognition and Patient Activation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Grp 1a Low Cognition, Low Activation
n=21 Participants
Subjects will receive an 8 week care transition intervention with an Advanced Practice Registered Nurse-Nurse Practitioner (APRN-NP) and Certified Nursing Assistant (CNA). The APRN-NP will guide the care transition intervention. This group will receive the most intense intervention. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation.
Grp 2a Low Cognition, High Activation
n=32 Participants
Subjects will receive an 8 week care transition intervention with an APRN-NP and CNA. The APRN-NP will guide the care transition intervention. This group will receive an intense intervention. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation and handling stressful situations.
Grp 3a Normal Cognition, Low Activation
n=20 Participants
Group 3a: Subjects will receive an 4 week care transition intervention with a Registered Nurse (RN) Coach. This group will be evaluated at four weeks, if the patient activation levels are still low, they will be referred to the 4 week APRN-NP and CNA. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided for areas of misunderstanding. The "teach back" method is used to validate knowledge, skills and confidence. Interventions are focused on motivation and developing personal behavioral goals.
Grp 4a Normal Cognition, High Activation
n=34 Participants
Subjects will receive the least intensive intervention delivered by a RN coach. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Focus is on maintaining behaviors during hardship and stress. Empowering, motivating and validating are strategies utilized.
Grp 1b Low Cognition, Low Activation Usual Care
n=27 Participants
The comparison Group for Group 1a intervention group
Grp 2b Low Cognition, High Activation Usual Care
n=36 Participants
The comparison Group for Group 2a intervention group
Grp 3b Normal Cognition, Low Activation
n=19 Participants
The comparison Group for Group 3a intervention group
Grp 4b Normal Cognition, High Activation Usual Care
n=33 Participants
The comparison group for Group 4a intervention group
Total
n=222 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
Age, Categorical
Between 18 and 65 years
9 Participants
n=5 Participants
15 Participants
n=7 Participants
13 Participants
n=5 Participants
25 Participants
n=4 Participants
13 Participants
n=21 Participants
15 Participants
n=10 Participants
10 Participants
n=115 Participants
22 Participants
n=24 Participants
122 Participants
n=42 Participants
Age, Categorical
>=65 years
12 Participants
n=5 Participants
17 Participants
n=7 Participants
7 Participants
n=5 Participants
9 Participants
n=4 Participants
14 Participants
n=21 Participants
21 Participants
n=10 Participants
9 Participants
n=115 Participants
11 Participants
n=24 Participants
100 Participants
n=42 Participants
Age, Continuous
65.2 years
STANDARD_DEVIATION 14.3 • n=5 Participants
64.3 years
STANDARD_DEVIATION 13.8 • n=7 Participants
55.9 years
STANDARD_DEVIATION 13.3 • n=5 Participants
56.6 years
STANDARD_DEVIATION 14.7 • n=4 Participants
66.1 years
STANDARD_DEVIATION 16.7 • n=21 Participants
63.4 years
STANDARD_DEVIATION 16.1 • n=10 Participants
59.3 years
STANDARD_DEVIATION 16.2 • n=115 Participants
59.3 years
STANDARD_DEVIATION 13.3 • n=24 Participants
61.3 years
STANDARD_DEVIATION 15.1 • n=42 Participants
Sex: Female, Male
Female
17 Participants
n=5 Participants
21 Participants
n=7 Participants
10 Participants
n=5 Participants
25 Participants
n=4 Participants
10 Participants
n=21 Participants
18 Participants
n=10 Participants
13 Participants
n=115 Participants
17 Participants
n=24 Participants
131 Participants
n=42 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants
11 Participants
n=7 Participants
10 Participants
n=5 Participants
9 Participants
n=4 Participants
17 Participants
n=21 Participants
18 Participants
n=10 Participants
6 Participants
n=115 Participants
16 Participants
n=24 Participants
91 Participants
n=42 Participants
Region of Enrollment
United States
21 Participants
n=5 Participants
32 Participants
n=7 Participants
20 Participants
n=5 Participants
34 Participants
n=4 Participants
27 Participants
n=21 Participants
36 Participants
n=10 Participants
19 Participants
n=115 Participants
33 Participants
n=24 Participants
222 Participants
n=42 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Health care utilization was evaluated 6 months after intervention completion.

Patient report of number of Emergency Department Visits and number of re-admissions to the hospital within a 6 month time period was measured. Validation data was obtained from the clinical sites.

Outcome measures

Outcome measures
Measure
Grp 1a Low Cognition, Low Activation
n=21 Participants
Subjects will receive an 8 week care transition intervention with an Advanced Practice Registered Nurse-Nurse Practitioner (APRN-NP) and Certified Nursing Assistant (CNA). The APRN-NP will guide the care transition intervention. This group will receive the most intense intervention. Grp 1 Low Cognition, Low Activation: The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation.
Grp 2a: Low Cognition, High Activation
n=32 Participants
Subjects will receive an 8 week care transition intervention with an APRN-NP and CNA. The APRN-NP will guide the care transition intervention. This group will receive an intense intervention. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation and handling stressful situations.
Grp 3a: Normal Cognition, Low Activation
n=20 Participants
Subjects will receive an 4 week care transition intervention with a Registered Nurse (RN) Coach. This group will be evaluated at four weeks, if the patient activation levels are still low, they will be referred to the 4 week APRN-NP and CNA. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided for areas of misunderstanding. The "teach back" method is used to validate knowledge, skills and confidence. Interventions are focused on motivation and developing personal behavioral goals.
Grp 4a; Normal Cognition, High Activation
n=34 Participants
Group 4: Subjects will receive the least intensive intervention delivered by a RN coach. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Focus is on maintaining behaviors during hardship and stress. Empowering, motivating and validating are strategies utilized.
Grp 1b: Low Cognition, Low Activation Usual Care
n=27 Participants
The comparison Group for Group 1a intervention group
Grp 2b: Low Cognition, High Activation Usual Care
n=36 Participants
The comparison Group for Group 2a intervention group
Grp 3b: Normal Cognition, Low Activation Usual Care
n=19 Participants
The comparison Group for Group 3a intervention group
Grp 4b Normal Cognition, High Activation Usual Care
n=33 Participants
The comparison group for Group 4a intervention group
Health Care Utilization
Emergency Department visits
7 events
8 events
4 events
3 events
5 events
13 events
8 events
10 events
Health Care Utilization
Readmissions
5 events
7 events
8 events
6 events
4 events
11 events
5 events
11 events

SECONDARY outcome

Timeframe: 6 months

Pain interference is one of the 7 domains of the Patient Reported Outcomes Measurement Information System (PROMIS). The PROMIS-29 is the shortest profile, with 4 questions asked for each of 7 domains, plus the single pain intensity item. PROMIS measures are scored on the T-score metric. Each short form is scored separately, yielding a total of 7 domain scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. There is no total score, but each axis forms its own score. Assessing patient perception of pain interference is measured as a 4-item short form scale on the PROMIS-29 survey. Each item is scored from 1-5 with a 1 indicating "not at all" and 5 indicating "very much." The T-Score for the average general population is 50. Higher scores mean more pain interference, thus a worse outcome. A score change of 2-3 points has been reported as clinically meaningful differences.

Outcome measures

Outcome measures
Measure
Grp 1a Low Cognition, Low Activation
n=14 Participants
Subjects will receive an 8 week care transition intervention with an Advanced Practice Registered Nurse-Nurse Practitioner (APRN-NP) and Certified Nursing Assistant (CNA). The APRN-NP will guide the care transition intervention. This group will receive the most intense intervention. Grp 1 Low Cognition, Low Activation: The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation.
Grp 2a: Low Cognition, High Activation
n=20 Participants
Subjects will receive an 8 week care transition intervention with an APRN-NP and CNA. The APRN-NP will guide the care transition intervention. This group will receive an intense intervention. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation and handling stressful situations.
Grp 3a: Normal Cognition, Low Activation
n=16 Participants
Subjects will receive an 4 week care transition intervention with a Registered Nurse (RN) Coach. This group will be evaluated at four weeks, if the patient activation levels are still low, they will be referred to the 4 week APRN-NP and CNA. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided for areas of misunderstanding. The "teach back" method is used to validate knowledge, skills and confidence. Interventions are focused on motivation and developing personal behavioral goals.
Grp 4a; Normal Cognition, High Activation
n=26 Participants
Group 4: Subjects will receive the least intensive intervention delivered by a RN coach. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Focus is on maintaining behaviors during hardship and stress. Empowering, motivating and validating are strategies utilized.
Grp 1b: Low Cognition, Low Activation Usual Care
n=16 Participants
The comparison Group for Group 1a intervention group
Grp 2b: Low Cognition, High Activation Usual Care
n=24 Participants
The comparison Group for Group 2a intervention group
Grp 3b: Normal Cognition, Low Activation Usual Care
n=12 Participants
The comparison Group for Group 3a intervention group
Grp 4b Normal Cognition, High Activation Usual Care
n=24 Participants
The comparison group for Group 4a intervention group
Patient-Reported Outcomes Measurement Information System - Pain Interference
58.8 score on a scale
Standard Deviation 9.8
57.0 score on a scale
Standard Deviation 11.5
61.4 score on a scale
Standard Deviation 10.9
54.2 score on a scale
Standard Deviation 8.5
56.0 score on a scale
Standard Deviation 11.0
55.4 score on a scale
Standard Deviation 11.0
56.6 score on a scale
Standard Deviation 10.9
52.4 score on a scale
Standard Deviation 9.2

SECONDARY outcome

Timeframe: 6 months after intervention

Physical Functioning is one of the 7 domains of the Patient Reported Outcomes Measurement Information System (PROMIS). The PROMIS-29 is the shortest profile, with 4 questions asked for each of 7 domains, plus the single pain intensity item. PROMIS measures are scored on the T-score metric. Each short form is scored separately, yielding a total of 7 domain scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. There is no total score, but each axis forms its own score. Physical functioning is measured as a 4-item short form subscale on the PROMIS-29 survey. The patients' answers to the Physical Functioning items are scored from 1-5, with a 1 indicating "unable to do" and 5 indicating "without any difficulty." Each subscales forms its own score subscale measures are scored on the T-score metric. High scores indicating better or higher physical functioning

Outcome measures

Outcome measures
Measure
Grp 1a Low Cognition, Low Activation
n=14 Participants
Subjects will receive an 8 week care transition intervention with an Advanced Practice Registered Nurse-Nurse Practitioner (APRN-NP) and Certified Nursing Assistant (CNA). The APRN-NP will guide the care transition intervention. This group will receive the most intense intervention. Grp 1 Low Cognition, Low Activation: The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation.
Grp 2a: Low Cognition, High Activation
n=21 Participants
Subjects will receive an 8 week care transition intervention with an APRN-NP and CNA. The APRN-NP will guide the care transition intervention. This group will receive an intense intervention. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation and handling stressful situations.
Grp 3a: Normal Cognition, Low Activation
n=16 Participants
Subjects will receive an 4 week care transition intervention with a Registered Nurse (RN) Coach. This group will be evaluated at four weeks, if the patient activation levels are still low, they will be referred to the 4 week APRN-NP and CNA. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided for areas of misunderstanding. The "teach back" method is used to validate knowledge, skills and confidence. Interventions are focused on motivation and developing personal behavioral goals.
Grp 4a; Normal Cognition, High Activation
n=26 Participants
Group 4: Subjects will receive the least intensive intervention delivered by a RN coach. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Focus is on maintaining behaviors during hardship and stress. Empowering, motivating and validating are strategies utilized.
Grp 1b: Low Cognition, Low Activation Usual Care
n=16 Participants
The comparison Group for Group 1a intervention group
Grp 2b: Low Cognition, High Activation Usual Care
n=24 Participants
The comparison Group for Group 2a intervention group
Grp 3b: Normal Cognition, Low Activation Usual Care
n=12 Participants
The comparison Group for Group 3a intervention group
Grp 4b Normal Cognition, High Activation Usual Care
n=24 Participants
The comparison group for Group 4a intervention group
Patient-Reported Outcomes Measurement Information System-Physical Functioning
39.1 score on a scale
Standard Deviation 9.2
42.1 score on a scale
Standard Deviation 10.2
36.3 score on a scale
Standard Deviation 10.4
43.6 score on a scale
Standard Deviation 8.6
41.1 score on a scale
Standard Deviation 8.1
43.8 score on a scale
Standard Deviation 9.2
40.8 score on a scale
Standard Deviation 9.4
44.5 score on a scale
Standard Deviation 10.6

SECONDARY outcome

Timeframe: 6 months

Ability to participate in social roles and activities is one of the 7 domains of the Patient Reported Outcomes Measurement Information System (PROMIS). The PROMIS-29 is the shortest profile, with 4 questions asked for each of 7 domains, plus the single pain intensity item. PROMIS measures are scored on the T-score metric. Each short form is scored separately, yielding a total of 7 domain scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. There is no total score, but each axis forms its own score. Ability to participate in social roles and activities is measured as a 4-item short form subscale on the PROMIS-29 survey. The patients' answers to the PROMIS-29 are scored from 1-5, with a 1 indicating "never" and 5 indicating "always." Each subscales forms its own score subscale measures are scored on the T-score metric. High scores indicating more ability to participate in social roles and activities.

Outcome measures

Outcome measures
Measure
Grp 1a Low Cognition, Low Activation
n=14 Participants
Subjects will receive an 8 week care transition intervention with an Advanced Practice Registered Nurse-Nurse Practitioner (APRN-NP) and Certified Nursing Assistant (CNA). The APRN-NP will guide the care transition intervention. This group will receive the most intense intervention. Grp 1 Low Cognition, Low Activation: The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation.
Grp 2a: Low Cognition, High Activation
n=19 Participants
Subjects will receive an 8 week care transition intervention with an APRN-NP and CNA. The APRN-NP will guide the care transition intervention. This group will receive an intense intervention. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation and handling stressful situations.
Grp 3a: Normal Cognition, Low Activation
n=16 Participants
Subjects will receive an 4 week care transition intervention with a Registered Nurse (RN) Coach. This group will be evaluated at four weeks, if the patient activation levels are still low, they will be referred to the 4 week APRN-NP and CNA. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided for areas of misunderstanding. The "teach back" method is used to validate knowledge, skills and confidence. Interventions are focused on motivation and developing personal behavioral goals.
Grp 4a; Normal Cognition, High Activation
n=26 Participants
Group 4: Subjects will receive the least intensive intervention delivered by a RN coach. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Focus is on maintaining behaviors during hardship and stress. Empowering, motivating and validating are strategies utilized.
Grp 1b: Low Cognition, Low Activation Usual Care
n=16 Participants
The comparison Group for Group 1a intervention group
Grp 2b: Low Cognition, High Activation Usual Care
n=24 Participants
The comparison Group for Group 2a intervention group
Grp 3b: Normal Cognition, Low Activation Usual Care
n=12 Participants
The comparison Group for Group 3a intervention group
Grp 4b Normal Cognition, High Activation Usual Care
n=24 Participants
The comparison group for Group 4a intervention group
Patient-Reported Outcomes Measurement Information System-Satisfaction With Social Roles
49.3 score on a scale
Standard Deviation 11.3
49.2 score on a scale
Standard Deviation 10.7
43.8 score on a scale
Standard Deviation 10.5
50.4 score on a scale
Standard Deviation 11.1
44.1 score on a scale
Standard Deviation 8.4
50.4 score on a scale
Standard Deviation 10.9
43.3 score on a scale
Standard Deviation 6.5
52.8 score on a scale
Standard Deviation 11.1

SECONDARY outcome

Timeframe: 6 months

Anxiety is one of the 7 domains of the Patient Reported Outcomes Measurement Information System (PROMIS). The PROMIS-29 is the shortest profile, with 4 questions asked for each of 7 domains, plus the single pain intensity item. PROMIS measures are scored on the T-score metric. Each short form is scored separately, yielding a total of 7 domain scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. There is no total score, but each axis forms its own score. Assessing patient anxiety is measured as a 4-item short form subscale on the PROMIS-29 survey. The patients' answers to the PROMIS-29 are scored from 1-5, with a 1 indicating "never" and 5 indicating "always." Each subscales forms its own score subscale measures are scored on the T-score metric. High scores indicating more anxiety and a worse outcome, and lower scores are indicative of less anxiety and a better outcome.

Outcome measures

Outcome measures
Measure
Grp 1a Low Cognition, Low Activation
n=14 Participants
Subjects will receive an 8 week care transition intervention with an Advanced Practice Registered Nurse-Nurse Practitioner (APRN-NP) and Certified Nursing Assistant (CNA). The APRN-NP will guide the care transition intervention. This group will receive the most intense intervention. Grp 1 Low Cognition, Low Activation: The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation.
Grp 2a: Low Cognition, High Activation
n=21 Participants
Subjects will receive an 8 week care transition intervention with an APRN-NP and CNA. The APRN-NP will guide the care transition intervention. This group will receive an intense intervention. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation and handling stressful situations.
Grp 3a: Normal Cognition, Low Activation
n=16 Participants
Subjects will receive an 4 week care transition intervention with a Registered Nurse (RN) Coach. This group will be evaluated at four weeks, if the patient activation levels are still low, they will be referred to the 4 week APRN-NP and CNA. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided for areas of misunderstanding. The "teach back" method is used to validate knowledge, skills and confidence. Interventions are focused on motivation and developing personal behavioral goals.
Grp 4a; Normal Cognition, High Activation
n=26 Participants
Group 4: Subjects will receive the least intensive intervention delivered by a RN coach. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Focus is on maintaining behaviors during hardship and stress. Empowering, motivating and validating are strategies utilized.
Grp 1b: Low Cognition, Low Activation Usual Care
n=16 Participants
The comparison Group for Group 1a intervention group
Grp 2b: Low Cognition, High Activation Usual Care
n=24 Participants
The comparison Group for Group 2a intervention group
Grp 3b: Normal Cognition, Low Activation Usual Care
n=12 Participants
The comparison Group for Group 3a intervention group
Grp 4b Normal Cognition, High Activation Usual Care
n=24 Participants
The comparison group for Group 4a intervention group
Patient-Reported Outcomes Measurement Information System- Anxiety
54.0 score on a scale
Standard Deviation 12.7
51.0 score on a scale
Standard Deviation 7.8
53.5 score on a scale
Standard Deviation 11.7
46.6 score on a scale
Standard Deviation 9.1
51.3 score on a scale
Standard Deviation 9.8
46.8 score on a scale
Standard Deviation 10.1
53.1 score on a scale
Standard Deviation 10.7
48.1 score on a scale
Standard Deviation 7.7

SECONDARY outcome

Timeframe: 6 months

Fatigue is one of the 7 domains of the Patient Reported Outcomes Measurement Information System (PROMIS). The PROMIS-29 is the shortest profile, with 4 questions asked for each of 7 domains, plus the single pain intensity item. PROMIS measures are scored on the T-score metric. Each short form is scored separately, yielding a total of 7 domain scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. There is no total score, but each axis forms its own score. Fatigue is measured as a 4-item short form subscale on the PROMIS-29 survey. The patients' answers to the PROMIS-29 are scored from 1-5, with a 1 indicating "not at all" and 5 indicating "very much." Each subscales forms its own score subscale measures are scored on the T-score metric. High scores indicating more fatigue and a worse outcome and lower scores are indicative of less fatigue and a better outcome.

Outcome measures

Outcome measures
Measure
Grp 1a Low Cognition, Low Activation
n=14 Participants
Subjects will receive an 8 week care transition intervention with an Advanced Practice Registered Nurse-Nurse Practitioner (APRN-NP) and Certified Nursing Assistant (CNA). The APRN-NP will guide the care transition intervention. This group will receive the most intense intervention. Grp 1 Low Cognition, Low Activation: The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation.
Grp 2a: Low Cognition, High Activation
n=21 Participants
Subjects will receive an 8 week care transition intervention with an APRN-NP and CNA. The APRN-NP will guide the care transition intervention. This group will receive an intense intervention. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation and handling stressful situations.
Grp 3a: Normal Cognition, Low Activation
n=16 Participants
Subjects will receive an 4 week care transition intervention with a Registered Nurse (RN) Coach. This group will be evaluated at four weeks, if the patient activation levels are still low, they will be referred to the 4 week APRN-NP and CNA. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided for areas of misunderstanding. The "teach back" method is used to validate knowledge, skills and confidence. Interventions are focused on motivation and developing personal behavioral goals.
Grp 4a; Normal Cognition, High Activation
n=26 Participants
Group 4: Subjects will receive the least intensive intervention delivered by a RN coach. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Focus is on maintaining behaviors during hardship and stress. Empowering, motivating and validating are strategies utilized.
Grp 1b: Low Cognition, Low Activation Usual Care
n=16 Participants
The comparison Group for Group 1a intervention group
Grp 2b: Low Cognition, High Activation Usual Care
n=24 Participants
The comparison Group for Group 2a intervention group
Grp 3b: Normal Cognition, Low Activation Usual Care
n=12 Participants
The comparison Group for Group 3a intervention group
Grp 4b Normal Cognition, High Activation Usual Care
n=24 Participants
The comparison group for Group 4a intervention group
Patient-Reported Outcomes Measurement Information System-Fatigue
54.8 score on a scale
Standard Deviation 10.9
54.3 score on a scale
Standard Deviation 11.0
56.7 score on a scale
Standard Deviation 12.2
50.5 score on a scale
Standard Deviation 10.5
55.9 score on a scale
Standard Deviation 10.5
49.3 score on a scale
Standard Deviation 11.2
59.1 score on a scale
Standard Deviation 8.5
48.0 score on a scale
Standard Deviation 8.3

SECONDARY outcome

Timeframe: 6 months

Depression is one of the 7 domains of the Patient Reported Outcomes Measurement Information System (PROMIS). The PROMIS-29 is the shortest profile, with 4 questions asked for each of 7 domains, plus the single pain intensity item. PROMIS measures are scored on the T-score metric. Each short form is scored separately, yielding a total of 7 domain scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. There is no total score, but each axis forms its own score. Depression is measured as a 4-item short form subscale on the PROMIS-29 survey. The patients' answers to the PROMIS-29 are scored from 1-5, with a 1 indicating "never" and 5 indicating "always." Each subscales forms its own score subscale measures are scored on the T-score metric. High scores indicating more feeling of depression and a worse outcome and lower scores are indicative of less depression and a better outcome.

Outcome measures

Outcome measures
Measure
Grp 1a Low Cognition, Low Activation
n=14 Participants
Subjects will receive an 8 week care transition intervention with an Advanced Practice Registered Nurse-Nurse Practitioner (APRN-NP) and Certified Nursing Assistant (CNA). The APRN-NP will guide the care transition intervention. This group will receive the most intense intervention. Grp 1 Low Cognition, Low Activation: The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation.
Grp 2a: Low Cognition, High Activation
n=21 Participants
Subjects will receive an 8 week care transition intervention with an APRN-NP and CNA. The APRN-NP will guide the care transition intervention. This group will receive an intense intervention. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation and handling stressful situations.
Grp 3a: Normal Cognition, Low Activation
n=16 Participants
Subjects will receive an 4 week care transition intervention with a Registered Nurse (RN) Coach. This group will be evaluated at four weeks, if the patient activation levels are still low, they will be referred to the 4 week APRN-NP and CNA. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided for areas of misunderstanding. The "teach back" method is used to validate knowledge, skills and confidence. Interventions are focused on motivation and developing personal behavioral goals.
Grp 4a; Normal Cognition, High Activation
n=26 Participants
Group 4: Subjects will receive the least intensive intervention delivered by a RN coach. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Focus is on maintaining behaviors during hardship and stress. Empowering, motivating and validating are strategies utilized.
Grp 1b: Low Cognition, Low Activation Usual Care
n=16 Participants
The comparison Group for Group 1a intervention group
Grp 2b: Low Cognition, High Activation Usual Care
n=24 Participants
The comparison Group for Group 2a intervention group
Grp 3b: Normal Cognition, Low Activation Usual Care
n=12 Participants
The comparison Group for Group 3a intervention group
Grp 4b Normal Cognition, High Activation Usual Care
n=24 Participants
The comparison group for Group 4a intervention group
Patient-Reported Outcomes Measurement Information System- Depression
55.2 score on a scale
Standard Deviation 10.9
50.5 score on a scale
Standard Deviation 10.4
54.4 score on a scale
Standard Deviation 11.0
49.4 score on a scale
Standard Deviation 9.1
52.6 score on a scale
Standard Deviation 12.9
47.4 score on a scale
Standard Deviation 10.1
53.3 score on a scale
Standard Deviation 8.2
48.7 score on a scale
Standard Deviation 8.0

SECONDARY outcome

Timeframe: 6 months

Sleep disturbance is one of the 7 domains of the Patient Reported Outcomes Measurement Information System (PROMIS). The PROMIS-29 is the shortest profile, with 4 questions asked for each of 7 domains, plus the single pain intensity item. PROMIS measures are scored on the T-score metric. Each short form is scored separately, yielding a total of 7 domain scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. There is no total score, but each axis forms its own score. Assessing sleep disturbance is measured as a 4-item short form subscale on the PROMIS-29 survey. The patients' answers to the sleep disturbance domain are scored from 1-5, with a 1 indicating "very good or very much" and 5 indicating "very poor or not at all." High scores indicating more sleep disturbance and a worse outcome, and lower scores are indicative of less sleep disturbance and a better outcome.

Outcome measures

Outcome measures
Measure
Grp 1a Low Cognition, Low Activation
n=14 Participants
Subjects will receive an 8 week care transition intervention with an Advanced Practice Registered Nurse-Nurse Practitioner (APRN-NP) and Certified Nursing Assistant (CNA). The APRN-NP will guide the care transition intervention. This group will receive the most intense intervention. Grp 1 Low Cognition, Low Activation: The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation.
Grp 2a: Low Cognition, High Activation
n=21 Participants
Subjects will receive an 8 week care transition intervention with an APRN-NP and CNA. The APRN-NP will guide the care transition intervention. This group will receive an intense intervention. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation and handling stressful situations.
Grp 3a: Normal Cognition, Low Activation
n=16 Participants
Subjects will receive an 4 week care transition intervention with a Registered Nurse (RN) Coach. This group will be evaluated at four weeks, if the patient activation levels are still low, they will be referred to the 4 week APRN-NP and CNA. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided for areas of misunderstanding. The "teach back" method is used to validate knowledge, skills and confidence. Interventions are focused on motivation and developing personal behavioral goals.
Grp 4a; Normal Cognition, High Activation
n=26 Participants
Group 4: Subjects will receive the least intensive intervention delivered by a RN coach. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Focus is on maintaining behaviors during hardship and stress. Empowering, motivating and validating are strategies utilized.
Grp 1b: Low Cognition, Low Activation Usual Care
n=16 Participants
The comparison Group for Group 1a intervention group
Grp 2b: Low Cognition, High Activation Usual Care
n=24 Participants
The comparison Group for Group 2a intervention group
Grp 3b: Normal Cognition, Low Activation Usual Care
n=12 Participants
The comparison Group for Group 3a intervention group
Grp 4b Normal Cognition, High Activation Usual Care
n=24 Participants
The comparison group for Group 4a intervention group
Patient-Reported Outcomes Measurement Information System-Sleep Deprivation
50.1 score on a scale
Standard Deviation 9.3
51.5 score on a scale
Standard Deviation 10.7
53.5 score on a scale
Standard Deviation 9.1
48.4 score on a scale
Standard Deviation 10.3
50.5 score on a scale
Standard Deviation 9.6
46.9 score on a scale
Standard Deviation 11.7
52.4 score on a scale
Standard Deviation 9.7
46.6 score on a scale
Standard Deviation 9.2

SECONDARY outcome

Timeframe: 6 months

The Patient Assessment of Chronic Illness Care (PACIC) Survey is a 20-item patient report instrument that assesses patient's receipt of clinical services and actions consistent with the Chronic Care Model. Respondents rate how often they experienced the content described in the item on a 5-point scale ranging from 1 (no or never) to 5 (yes or always). Patients rated the care received from their health care team. The PACIC consists of 5 scales and an overall summary score, each having good internal consistency for brief scales. The five subscales were Patient Activation; Delivery System/ Decision Support; Goal Setting; Problem-solving/Contextual Counseling; and Follow-up/ Coordination. Overall mean summary score (range 1-5) was used in analysis. Higher scores are more positive rating of their receipt of clinical services.

Outcome measures

Outcome measures
Measure
Grp 1a Low Cognition, Low Activation
n=14 Participants
Subjects will receive an 8 week care transition intervention with an Advanced Practice Registered Nurse-Nurse Practitioner (APRN-NP) and Certified Nursing Assistant (CNA). The APRN-NP will guide the care transition intervention. This group will receive the most intense intervention. Grp 1 Low Cognition, Low Activation: The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation.
Grp 2a: Low Cognition, High Activation
n=20 Participants
Subjects will receive an 8 week care transition intervention with an APRN-NP and CNA. The APRN-NP will guide the care transition intervention. This group will receive an intense intervention. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation and handling stressful situations.
Grp 3a: Normal Cognition, Low Activation
n=16 Participants
Subjects will receive an 4 week care transition intervention with a Registered Nurse (RN) Coach. This group will be evaluated at four weeks, if the patient activation levels are still low, they will be referred to the 4 week APRN-NP and CNA. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided for areas of misunderstanding. The "teach back" method is used to validate knowledge, skills and confidence. Interventions are focused on motivation and developing personal behavioral goals.
Grp 4a; Normal Cognition, High Activation
n=25 Participants
Group 4: Subjects will receive the least intensive intervention delivered by a RN coach. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Focus is on maintaining behaviors during hardship and stress. Empowering, motivating and validating are strategies utilized.
Grp 1b: Low Cognition, Low Activation Usual Care
n=16 Participants
The comparison Group for Group 1a intervention group
Grp 2b: Low Cognition, High Activation Usual Care
n=22 Participants
The comparison Group for Group 2a intervention group
Grp 3b: Normal Cognition, Low Activation Usual Care
n=12 Participants
The comparison Group for Group 3a intervention group
Grp 4b Normal Cognition, High Activation Usual Care
n=20 Participants
The comparison group for Group 4a intervention group
Patient Assessment of Chronic Illness Care
2.9 score on a scale
Standard Deviation 1.2
2.9 score on a scale
Standard Deviation 1.0
2.5 score on a scale
Standard Deviation 1.0
3.0 score on a scale
Standard Deviation 1.0
2.8 score on a scale
Standard Deviation 1.1
3.2 score on a scale
Standard Deviation .9
2.5 score on a scale
Standard Deviation 1.0
2.6 score on a scale
Standard Deviation .9

SECONDARY outcome

Timeframe: 6 months

Quality of life was measured by the EuroQol-5 (EQ-5D) and consists of 1 question for each of the 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Patients indicate their health state for each of the 5 dimensions. The 5 responses give a health state represented by a 5-digit number (for example, 12231) corresponding to response categories reported by patients for the dimensions. Health states are scored to give the EQ-5D-5L index using a scoring algorithm from a value set derived from valuation tasks typically undertaken with general population samples. The five dimensions are combined into a 5-digit number that describes the patient's health state. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state. Negative values represent health states perceived as worse than dead, which is equal to 0.

Outcome measures

Outcome measures
Measure
Grp 1a Low Cognition, Low Activation
n=13 Participants
Subjects will receive an 8 week care transition intervention with an Advanced Practice Registered Nurse-Nurse Practitioner (APRN-NP) and Certified Nursing Assistant (CNA). The APRN-NP will guide the care transition intervention. This group will receive the most intense intervention. Grp 1 Low Cognition, Low Activation: The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation.
Grp 2a: Low Cognition, High Activation
n=21 Participants
Subjects will receive an 8 week care transition intervention with an APRN-NP and CNA. The APRN-NP will guide the care transition intervention. This group will receive an intense intervention. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation and handling stressful situations.
Grp 3a: Normal Cognition, Low Activation
n=16 Participants
Subjects will receive an 4 week care transition intervention with a Registered Nurse (RN) Coach. This group will be evaluated at four weeks, if the patient activation levels are still low, they will be referred to the 4 week APRN-NP and CNA. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided for areas of misunderstanding. The "teach back" method is used to validate knowledge, skills and confidence. Interventions are focused on motivation and developing personal behavioral goals.
Grp 4a; Normal Cognition, High Activation
n=26 Participants
Group 4: Subjects will receive the least intensive intervention delivered by a RN coach. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Focus is on maintaining behaviors during hardship and stress. Empowering, motivating and validating are strategies utilized.
Grp 1b: Low Cognition, Low Activation Usual Care
n=16 Participants
The comparison Group for Group 1a intervention group
Grp 2b: Low Cognition, High Activation Usual Care
n=24 Participants
The comparison Group for Group 2a intervention group
Grp 3b: Normal Cognition, Low Activation Usual Care
n=12 Participants
The comparison Group for Group 3a intervention group
Grp 4b Normal Cognition, High Activation Usual Care
n=24 Participants
The comparison group for Group 4a intervention group
Health Related Quality of Life EuroQol-5D (EQ-5D)
0.68 score on a scale
Standard Deviation 0.24
0.76 score on a scale
Standard Deviation 0.14
0.65 score on a scale
Standard Deviation 0.17
0.80 score on a scale
Standard Deviation 0.09
0.72 score on a scale
Standard Deviation 0.20
0.77 score on a scale
Standard Deviation 0.19
0.76 score on a scale
Standard Deviation 0.08
0.80 score on a scale
Standard Deviation 0.11

SECONDARY outcome

Timeframe: 6 months

Used alongside the EuroQol-5D (EQ-5D), the EQ visual analog scale (VAS) is a 20 cm VAS "assessing your own health today" with endpoints labeled "Best imaginable health state" (100) and "Worst imaginable health state" (0). EQ VAS scores range from 0 to 100, where 100 is the best possible health state.

Outcome measures

Outcome measures
Measure
Grp 1a Low Cognition, Low Activation
n=14 Participants
Subjects will receive an 8 week care transition intervention with an Advanced Practice Registered Nurse-Nurse Practitioner (APRN-NP) and Certified Nursing Assistant (CNA). The APRN-NP will guide the care transition intervention. This group will receive the most intense intervention. Grp 1 Low Cognition, Low Activation: The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation.
Grp 2a: Low Cognition, High Activation
n=21 Participants
Subjects will receive an 8 week care transition intervention with an APRN-NP and CNA. The APRN-NP will guide the care transition intervention. This group will receive an intense intervention. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The "teach back" method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation and handling stressful situations.
Grp 3a: Normal Cognition, Low Activation
n=16 Participants
Subjects will receive an 4 week care transition intervention with a Registered Nurse (RN) Coach. This group will be evaluated at four weeks, if the patient activation levels are still low, they will be referred to the 4 week APRN-NP and CNA. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided for areas of misunderstanding. The "teach back" method is used to validate knowledge, skills and confidence. Interventions are focused on motivation and developing personal behavioral goals.
Grp 4a; Normal Cognition, High Activation
n=26 Participants
Group 4: Subjects will receive the least intensive intervention delivered by a RN coach. The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Focus is on maintaining behaviors during hardship and stress. Empowering, motivating and validating are strategies utilized.
Grp 1b: Low Cognition, Low Activation Usual Care
n=16 Participants
The comparison Group for Group 1a intervention group
Grp 2b: Low Cognition, High Activation Usual Care
n=24 Participants
The comparison Group for Group 2a intervention group
Grp 3b: Normal Cognition, Low Activation Usual Care
n=12 Participants
The comparison Group for Group 3a intervention group
Grp 4b Normal Cognition, High Activation Usual Care
n=24 Participants
The comparison group for Group 4a intervention group
EQ-5D Visual Analog Scale (VAS)
68.2 score on a scale
Standard Deviation 28.3
67.2 score on a scale
Standard Deviation 27.2
62.4 score on a scale
Standard Deviation 23.0
73.5 score on a scale
Standard Deviation 18.3
61.3 score on a scale
Standard Deviation 19.6
79.0 score on a scale
Standard Deviation 17.3
72.9 score on a scale
Standard Deviation 13.4
77.2 score on a scale
Standard Deviation 13.0

Adverse Events

Grp 1a Low Cognition, Low Activation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Grp 2a Low Cognition, High Activation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Grp 3a Normal Cognition, Low Activation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Grp 4a Normal Cognition, High Activation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Grp 1b Low Cognition, Low Activation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Grp 2b Low Cognition, High Activation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Grp 3b Normal Cognition, Low Activation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Grp 4b Normal Cognition, High Activation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lani Zimmerman

University of Nebraska Medical Center

Phone: 402-472-3847

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place